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IRCT201403039014N29 IRCT 2014-03-11 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy Effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy: a double blinded randomized clinical trial 2012-03-20 anticipated 100 Complete https://irct.ir/trial/9468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control group using tossing coin. Blinding: Although informed consent will be taken from all volunteers, however all interventions including acupuncture and injection of metoclopramide and dexamethasone will be done during anesthesia. Thus the patients are unconscious and will be unaware of the intervention. In addition, the physician, who conduct the intervention is different from the physician who will examine the patients and the examiner will not be aware of the intervention. Therefore, the trial will be run as double blinded. 2 Nausea and vomiting. Intervention 1: Performing acupuncture through inserting special needle at point of P6 in front of the elbow immediately after anesthesia and removing it before intubation and transferring the patient to the recovery room. Intervention 2: Prescribing single dose of metoclopramide 10 mg intravenously and single dose of dexamethasone 10 mg intravenously before intubation and transferring the patient to the recovery room.
public Dr Shahpour Shoja
Beasat Hospital, Shahed Square, Behesh Ave.
Hamadan Iran (Islamic Republic of) +98 81 1341 6392 shshoja@hotmail.com Beasat Hospital scientific Dr Ebrahim Khoshraftar
Beasat Hospital, Shahed Square, Behesh Ave.
Hamadan Iran (Islamic Republic of) +98 81 1341 6392 khoshraftar@umsha.ac.ir Beasat Hospital Iran (Islamic Republic of) Inclusion criteria: (a); candidate for elective laparotomy or cholecystectomy; (b) age of 12 to 70 years. Exclusion criteria: (a) narcotic abuse; (b) alcohol abuse; (c) history of neurological or psychological diseases; (d) presence of scar or infection at site of needling on wrist or elbow; (e) history of gastrointestinal disorder or ear diseases that may lead to nausea or vomiting; (f) prolongation of surgery longer than two hours. 12 years 70 years Both R11 Nausea and vomiting Treatment - Drugs Treatment - Other Performing acupuncture through inserting special needle at point of P6 in front of the elbow immediately after anesthesia and removing it before intubation and transferring the patient to the recovery room. Prescribing single dose of metoclopramide 10 mg intravenously and single dose of dexamethasone 10 mg intravenously before intubation and transferring the patient to the recovery room. Number of times nausea and vomiting occur. Timepoint: during the period that the patient stays in recovery room. Method of measurement: through question and clinical observation. Local reaction at site of acupuncture needle. Timepoint: during the period that the patient stays in recovery room. Method of measurement: through clinical examination. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2013-09-10 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)